PMA P220020

Device: Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit
Applicant: Sirtex Medical, Inc.
Product code: QVG
Decision date: 2025-09-03
Generic name: Embolization Agent, Vascular
Approval order statement: Approval for a contract manufacturing site located in Wilmington, Massachusetts and to change the legal manufacturer address

Current openFDA PMA Record#

Device: Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit
Applicant: Sirtex Medical, Inc.
PMA number: P220020
Supplement: S005
Product code: QVG
Generic name: Embolization Agent, Vascular
Decision date: 2025-09-03
Decision code: APPR
Date received: 2025-03-17
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a contract manufacturing site located in Wilmington, Massachusetts and to change the legal manufacturer address